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Trial Title:
TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors
NCT ID:
NCT06438783
Condition:
Osteosarcoma
Other Solid Tumors
Conditions: Official terms:
Osteosarcoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
1200mg of TQB2928 injection+Anlotinib
Description:
TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody
targeting Cluster of Differentiation 47 (CD47).
Arm group label:
1200mg of TQB2928 injection +Anlotinib
Intervention type:
Drug
Intervention name:
1800mg of TQB2928 injection+Anlotinib
Description:
TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47.
Arm group label:
1800mg of TQB2928 injection+Anlotinib
Summary:
This is a multicenter, open-label, multi-cohort Phase Ib trial to evaluate the efficacy
and safety of TQB2928 injection combined with anlotinib hydrochloride capsule in patients
with relapsed/metastatic osteosarcoma and other relapsed/metastatic solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathological diagnosis of high-grade osteosarcoma(cohort I),dedifferentiated
liposarcoma or polytypic liposarcoma(cohort II),unsuitable for local treatment;
- The requirements for front-line treatment received by subjects are as follows:
1. Subjects with osteosarcoma have failed at least first-line chemotherapy and are
not suitable for re-receiving first-line chemotherapy ,or progression within 6
months of the end of first-line therapy;
2. Subjects with dedifferentiated liposarcoma or polytype liposarcoma who have
received at least first-line chemotherapy failure for recurrent/metastatic
sites or relapse during postoperative adjuvant chemotherapy or within 6 months
after treatment(considered first-line treatment failure).
Exclusion Criteria:
- History of hemolytic anemia from any cause (including Evans syndrome) within 3
months prior to first dosing;
- Subjects with osteosarcoma or dedifferentiated liposarcoma/polytype liposarcoma who
have previously used antiangiogenic tyrosine kinase inhibitors (TKI) or bevacizumab
or its biosimilar, such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib,
regorafenib, fruquintinib;
- Previous antibody or fusion protein or small molecule drug targeting CD47 or
Signal-regulatory protein α (SIRRP-α).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing jishuitan hospital
Address:
City:
Beijing
Zip:
100035
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaohui Niu, Doctor
Phone:
13801132522
Email:
niuxiaohuiJST@163.com
Facility:
Name:
Pekjing university people's hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Xie
Phone:
13401044719
Email:
xie.lu@hotmail.com
Facility:
Name:
Beijing cancer hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lu Si, Doctor
Phone:
13810700214
Email:
silu15_silu@126.com
Facility:
Name:
Hunan cancer hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xianan Li, Doctor
Phone:
18874933879
Email:
lixianan2001@163.com
Facility:
Name:
Tianjin medical university cancer institute&hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guowen Wang, Doctor
Phone:
18622221109
Email:
wgwhrb@163.com
Start date:
February 15, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06438783
